Tony Hagen

With insulin originator product patents expiring, drug companies are seeking to extend exclusivities via patents on injectors and other delivery products.

As part of a project to build the first biosimilar factory in Malaysia, one of the initial products would be halal certified.

Celltrion Healthcare said an antiviral drug candidate is moving along in trials as a potential treatment for coronavirus 2019 (COVID-19).

Investigators found that process complexities have created numerous difficulties for biosimilar developers in regulatory filings, but they anticipate that the success rate will improve with experience and improved guidance.

An upcoming webinar from MJH Life Sciences™ will address the payer rebate deals that limit provider choice of biosimilars and complicate clinical pharmacy operations.

The transition from reference to biosimilar etanercept was safe and effective in patients with stable rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA), according to updated findings from the BENEFIT study.

The House Appropriations Committee has called upon CMS to increase access to biosimilars.

The rise of biologics as a class of prescription spending is fueling a trend toward longer exclusivity periods, which ultimately makes access more remote, authors of a new study said.

A victory for Amgen and a defeat for Sandoz pushes biosimilar competition in the etanercept market out to 2029 unless Sandoz or Samsung Bioepis can eke out headway against Enbrel's patent wall.

India's medical authorities approve Biocon Biologics' itolizumab, an anti-CD6 IgG1 monoclonal antibody, for emergency treatment of cytokine release syndrome in patients with coronavirus disease 2019 (COVID-19).

With a couple of recent biosimilar approvals, the FDA has vastly improved on the pace from the first 5 months of this year, during which no biosimilars were approved.

In court filings this week, Genentech and Amgen laid to rest their long-running dispute over the marketing of bevacizumab and trastuzumab biosimilars that challenged Genentech's dominance of the market for those products.

The FDA has approved Fujifilm Kyowa Kirin Biologics's Hulio adalimumab biosimilar, making it the sixth adalimumab biosimilar approved in the United States. However, none will be launched before 2023 because of the strength of AbbVie's exclusivity rights for Humira, the reference product. Hulio launched in Europe in 2018.

Wayne Winegarden, PhD, director of the Center for Medical Economics and Innovation, explains that misaligned incentives are preventing the United States from realizing full benefit from biosimilars.

In upholding a lower court ruling, a federal circuit court has decided that Amgen gave enough notice prior to launching its bevacizumab biosimilar. The court decision has frustrated an attempt by Genentech to block sales of the product.

After a study from India suggested a higher incidence of adverse reactions in patients using biosimilar filgrastims, 2 European biosimilar consultants and oncologists raised objections to the study’s methodology.

Japanese authorities have given marketing approval for the first adalimumab biosimilar in that country.

A new scorecard system developed by IQVIA rates the health and sustainability of biosimilars markets across Europe.

The US Oncology Network is pushing to get more biosimilars into utilization, Robert M. Rifkin, MD, told The Center for Biosimilars® in an interview.

Based on clinical studies on dosing, efficacy, and pharmacokinetics, European authorities have recommended Celltrion's subcutaneous infliximab biosimilar (Remsima SC) for 5 new indications.

New prediction methodology for calculating biosimilar application fees will help the FDA cover its costs and respond quickly to changes in demand, officials said at a public meeting.

Republican opponents of the Affordable Care Act (ACA), led by the state of Texas, fired opening salvos in the Supreme Court case over the landmark law's constitutionality. If the entire law is thrown out, approval for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA) would disappear, too.

There is much inconsistency in the way physicians transition patients from insulin degludec to insulin glargine upon hospital admission, leading to higher risk especially for patients with type 1 diabetes, according to a study presented at the American Diabetes Association 80th Scientific Sessions online conference.

HLX04, a bevacizumab biosimilar candidate targeted at the colorectal and non–small cell lung cancer markets, met a phase 3 study primary end point, Shanghai Henlius Biotech said.

Eli Lilly gets FDA approval for a new formulation of insulin lispro and offers it at the out-of-pocket cap of $35 for a monthly supply for patients with or without insurance.

Studies on switching and retention for adalimumab and etanercept biosimilars yielded positive data, according to abstracts presented at the EULAR 2020 Congress.

A study presented at the European League Against Rheumatism conference suggested that French rheumatologists have good knowledge of biosimilars but lack the confidence to use them.

A rituximab biosimilar developed by Celltrion Healthcare demonstrates safety and efficacy in patients with relapsed or refractory aggressive B-cell lymphoma, in findings presented at EHA25 Virtual, the annual meeting of the European Hematology Association.

The infliximab biosimilar CT-P13 delivered positive results in studies presented at the European League Against Rheumatism's European E-Congress of Rheumatology 2020.

Lannett’s insulin glargine biosimilar candidate will break new ground as it moves through the 351(k) review pathway, according to Ha Kung Wong, an intellectual property law attorney with Venable of New York.